U.K.-based Atlas Group London Ltd. said it has completed virtual testing of its Icas platform and achieved its proof-of-concept target. The end-to-end system enables rapid delivery of high-quality facilities at fixed costs.
Beckman Coulter Life Sciences, of Indianapolis, said the U.S. FDA has listed its RNAdvance Viral XP to the list of acceptable extraction methods for use in the CDC’s emergency use authorized COVID-19 test referenced in the FDA’s FAQ for testing for SARS-CoV-2.
CHF Solutions Inc., of Eden Prairie, Minn., has inked a distribution agreement with Transimed Medical Equipment Co. LLC, of Dubai, covering the United Arab Emirates, its first in the Middle East.
Waltham, Mass.-based software intelligence company Dynatrace Inc. reported that Ert Inc., of Laurel, Md., is using its artificial intelligence-powered Davis system to automate development and operations processes and speed the delivery of new applications.
Toronto-based startup Epineuron Technologies Inc. said it has completed a funding round to support development and clinical validation of its temporary peripheral nerve regeneration technology. The financing – details of which were not disclosed – was led by the Ontario Centers for Excellence and Ontario Brain Institute.
Ergotron Inc., of St. Paul, Minn., reported the launch of its Thermal Imaging Cart with Onboard Power designed to quickly detect a temperature in spaces where groups of people gather.
Guided Therapeutics Inc., of Peachtree Corners, Ga., and its partner, Shandong Yaohua Medical Instrument Corp., of Shandong, China, have completed software changes and documentation required by China’s National Medical Products Administration for marketing approval in the country.
I-Med Pharma Inc., of Dollard-des -Ormeaux, Quebec, said it is collaborating with Kmg International Ltd. to manufacture and supply personal protective equipment and COVID-19 diagnostic tests to help respond to the need for these products in Canada, the U.S. and Europe.
Itm Isotopen Technologien München AG, of Munich, Germany, has rebranded its subsidiary, Itg Isotope Technologies Garching GmbH, to Itg Medical Isotopes GmbH.
Portland, Ore.-based Jama Software Inc. has released Jama Connect for medical device development, a tool to help medtech developers better manage device requirements, risk and design control.
Laboratory Corp. of America Holdings Inc., of Burlington, N.C., said it is expanding its decentralized trials technology ecosystem via an alliance with Medable Inc., a provider of software for digital clinical trials based in Palo Alto, Calif.
Life Spine Inc., of Huntley, Ill., said the first surgeries with the Dyna-Link Ti Stand-Alone anterior lumbar interbody fusion spacer system have taken place.
Netsmart Technologies Inc., of Overland Park, Kan., launched a COVID-19 mobile screening solution to help organizations safely reopen as stay at home orders are lifted around the country.
Oncimmune Holdings plc, of Nottingham, U.K., said it has signed a further contract with Roche Holding AG, of Basel, Switzerland. The project will explore the baseline and on-treatment autoantibody profiles as biomarkers in patients that received cancer immunotherapy, using Oncimmune's proprietary Serotag biomarker discovery platform. This contract, which has a substantial upfront element, will commence immediately, with initial results scheduled to be provided to Roche within three months, and project completion by November 2020. Financial terms were not reported.
Orthogenrx Inc., a Doylestown, Pa.-based developer of treatments for knee pain caused by osteoarthritis, reported the launch of two pricing option programs. The Trivisc Direct Purchase Program enables patients without insurance coverage to purchase product directly through an exclusive network of pharmacy partners, at a fair and consistent price. The Trivisc Patient Assistance Program offers access to Trivisc for patients without the financial resources to pay for the treatment by providing the product at no cost.
Hayward, Calif.-based Reflexion Medical Inc., a therapeutic oncology company developing biology-guided radiotherapy (BgRT) for treating all stages of cancer, reported a clinical collaboration with Merck & Co. Inc., of Kenilworth, N.J., to evaluate the safety and efficacy of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with BgRT in multiple late-stage cancers, including non-small-cell lung cancer, in two randomized controlled clinical trials. Terms of the clinical collaboration were not disclosed.
Renovacare Inc., Roseland, N.J.-based developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues, said it has expanded its engagement with Mcra LLC, a U.S. regulatory group for medical devices and biologics to continue to advance the company’s FDA regulatory pathway program.
Synergy Laboratories Inc., of Mobile, Ala., said it is adding a new testing platform to augment its vital COVID-19 diagnostic capabilities. The new testing capability will utilize a Roche Cobas 6800 molecular testing unit. The new platform will more than double Synergy’s reverse transcription polymerase chain reaction testing capability to approximately 2,500 tests per day.
Vaxxas Inc., which has a presence in Sydney and Cambridge, Mass., said that Merck & Co. Inc., of Kenilworth, N.J., has exercised an option to utilize the former's High Density Microarray Patch platform for a vaccine candidate. Under the collaboration agreement, originally signed in 2012, through the exercise of this option, Merck gains exclusive worldwide rights to develop and commercialize an undisclosed vaccine using the technology. Vaxxas will receive $12 million in a combination of equity funding and option fees. In addition, Vaxxas is eligible to receive future option, development and commercial milestone payments. Merck will fund any requested additional research activities conducted by Vaxxas and is responsible for clinical development.